Palonosetron versus ondansetron for prophylaxis of postoperative nausea and vomiting following craniotomy: A prospective randomized controlled trial

Abstract

Abstract Background: Postoperative nausea and vomiting (PONV) is a common adverse event that may occur in as many as 80% of high-risk patients after general anesthesia. Intracranial neurosurgery, especially infratentorial type, is considered as an additional PONV risk factor. We performed our study to compare antiemetic efficacy of ondansetron versus palonosetron for prevention of PONV in patients undergoing elective neurosurgery for intracranial tumors remove. Methods: 80 patients 18 to 80 years of age with ASA physical status I or II underwent elective neurosurgery for intracranial tumor removal under general anesthesia were randomized into two groups in 1:1 ratio to receive ondansetron (8 mg) or palonosetron (0.075 mg). Each group included two equal subgroups based on the type of procedure: supratentorial and infratentorial. In both subgroups we provided IV anesthesia based on propofol. Both antiemetic drugs were given intravenously before closing the dura mater. In most patients dexamethasone 8 mg for PONV prevention was also used. Incidence of PONV in 48 hours period after surgery as primary outcome was evaluated. PONV scale was used for assessment at 30 min, 1, 2, 6, 12, 24, and 48 hours after extubation postoperatively. Patient-related risk factors for PONV, intervention characteristics, visual analog scale (VAS) pain scores at 30 min, 1, 2, 6, 12, 24, and 48 hours after extubation postoperatively, rate of rescue antiemetic drug use were also recorded. Results: The final analysis included 78 patients (38 in palonosetron group and 40 in ondansetron group). Palonosetron significantly decreased incidence of PONV in infratentorial subgroup of patients compared to ondansetron (70% vs. 28%, respectively; RR=0.40; 95% СI: 0.18-0.89). However, the difference was not statistically significant in the general cohort of study patients (26.3% vs. 45%, respectively; RR=0.58; 95% СI: 0.31-1.10). The administration of palonosetron was not associated with decreased use of rescue antiemetics in either the palonosetron or the ondansetron group (15.8% vs. 22.5%, respectively; p=0.57) nor in the infratentorial subgroup that received palonosetron compared to which received ondansetron (16.6% vs. 40%, respectively; p=0.159). Conclusion: Intraoperative palonosetron was more effective than ondansetron for prevention of PONV in patients following infratentorial craniotomy. Risk reduction of PONV after craniotomy in general was insignificant.